BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXZERO NEEDLELESS CONNECTOR

    MDR report key: 10049829 · Received May 12, 2020

    Report

    Report Number
    9616066-2020-01518
    Event Type
    Malfunction
    Date Received
    May 12, 2020
    Date of Event
    April 17, 2020
    Report Date
    April 17, 2020
    Manufacturer
    CFN MEXICO 215 SA DE CV
    Product Code
    FPA
    PMA / PMN Number
    K140831
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    MZ1000 510K: THIS IS AN INTERNATIONAL CODE - THE MODEL#/CATALOG# IDENTIFIED IS A CAREFUSION PRODUCT WHICH IS SAME OR SIMILAR TO A DEVICE THAT IS APPROVED FOR SALE DOMESTICALLY. THE DOMESTIC SIMILAR LIST NUMBER IS MZ5302. THE 510K NUMBER PROVIDED IS FOR THE DOMESTIC SIMILAR PRODUCT.- K140831 DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: A SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION OF THIS FEEDBACK; HOWEVER THE CUSTOMER INDICATES THAT A CRACK WAS IDENTIFIED TO THE MAXZERO DEVICE WHICH RESULTED IN LEAKAGE. THE CONNECTING PRODUCT WAS NOT RETURNED TO ASSIST THE INVESTIGATION. ROOT CAUSE ANALYSIS: THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. IN THIS INSTANCE A LOT NUMBER WAS NOT AVAILABLE AND THEREFORE IT IS NOT POSSIBLE TO PERFORM A REVIEW OF THE PRODUCTION DOCUMENTATION FOR THIS PARTICULAR PRODUCT. THE ROOT CAUSE OF THE CUSTOMER¿S EXPERIENCE COULD NOT BE DETERMINED IN THIS INSTANCE. WITHOUT A SAMPLE IT IS NOT POSSIBLE TO DETERMINE WHETHER A MANUFACTURING DEFECT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. INVESTIGATION CONCLUSION: THE ROOT CAUSE OF THE CUSTOMER¿S EXPERIENCE COULD NOT BE DETERMINED IN THIS INSTANCE. WITHOUT A SAMPLE IT IS NOT POSSIBLE TO DETERMINE WHETHER A MANUFACTURING DEFECT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. PLEASE NOTE, PREVIOUS INVESTIGATIONS INTO COMPLAINTS OF THIS NATURE COULD NOT IDENTIFY A DEFINITIVE ROOT CAUSE FOR CRACKS TO THE LUER OF THE MAXZERO; HOWEVER IT IS POSSIBLE THAT THE CRACKING WAS CAUSED OR CONTRIBUTED TO BY A COMBINATION OF DIFFERENT FACTORS, INCLUDING PROLONGED USE OF SUBSTANCES THAT ARE AGGRESSIVE TO PLASTICS, OVER-TORQUE OF THE COMPONENT DURING CONNECTION WITH THE MALE LUER, OR USE OF A MALE LUER THAT IS NOT COMPLIANT TO ISO STANDARDS. FROM THE LIMITED INFORMATION AVAILABLE IT WAS NOT POSSIBLE TO SPECULATE WHICH OF THESE FACTORS WERE KEY CONTRIBUTORS TO THE REPORTED ISSUE. A REVIEW OF THE CUSTOMER FEEDBACK DATABASE INDICATES THAT COMPLAINTS OF THIS NATURE ARE RARE AND THERE IS CURRENTLY NO TREND FOR ISSUES OF THIS NATURE AGAINST THE MAXZERO PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MAXZERO NEEDLELESS CONNECTOR LEAKED AND A CRACK WAS FOUND ON THE LUER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN THE CUSTOMER USED MZ, LEAKAGE WAS FOUND AND THEN CRACK ON THE LUER CONNECTION WAS FOUND. NO INFORMATION FOR USED PERIOD, CONNECTED DEVICE AND USED MEDICATION WAS PROVIDED FROM THE CUSTOMER. NO HEALTH HAZARD TO PATIENT WAS REPORTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513090 MAXZERO NEEDLELESS CONNECTOR INTRAVASCULAR ADMINISTRATION SET FPA CFN MEXICO 215 SA DE CV MZ1000 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other